The following data is part of a premarket notification filed by Elekta Instruments, Inc. with the FDA for Es-100 Accessories.
| Device ID | K932261 |
| 510k Number | K932261 |
| Device Name: | ES-100 ACCESSORIES |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | ELEKTA INSTRUMENTS, INC. 1926 NORTHLAKE PKWY. Tucker, GA 30084 |
| Contact | Marc Buntaine |
| Correspondent | Marc Buntaine ELEKTA INSTRUMENTS, INC. 1926 NORTHLAKE PKWY. Tucker, GA 30084 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-20 |
| Decision Date | 1994-01-07 |